Panel members at the time of adoption
Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) was asked to carry out the additional assessment for UV-treated bread as a novel food (NF) in the context of Regulation (EC) No 258/97, taking into account the comments and objections of a scientific nature raised by Member States. The NF is bread to which a treatment with UV radiation is applied after baking in order to convert ergosterol, which is present in bread as a result of yeast fermentation, to vitamin D2. The provided compositional data, the specifications (i.e. vitamin D2 content of 0.75–3 μg/100 g in the UV-treated bread, 1–5 g/100 g of yeast in the dough) and the data from batch testing do not give rise to safety concerns. The data provided on the production process are sufficient and do not give rise to safety concerns. The Panel considers that even if it is conservatively assumed that all consumed breads are UV-treated and contain the maximum proposed amount of 3 µg vitamin D2/100 g, it is highly unlikely that tolerable upper intake levels for vitamin D, established by EFSA for various age groups, will be exceeded. The NF is not nutritionally disadvantageous. Under certain conditions, UV treatment may result in reactions of biomolecules. However, the levels of potential reaction products that may be formed under the employed conditions are low compared with the reactions induced by the baking process. Therefore, the Panel considers that it is not necessary to perform additional analyses and that the absence of toxicological studies with the novel food is acceptable. The risk of allergic reactions to the NF is not dissimilar to that associated with conventional bread. The Panel considers that bread enriched with vitamin D2 through UV treatment is safe under the conditions of use as specified by the applicant.